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July 24, 2007

JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

THIS WEEK'S CONTENT

JAMA NEWS RELEASES
(Embargoed for Release: 3:00 p.m. CT, Tuesday, July 24, 2007)


JAMA NEWS RELEASES

>   USE OF HIP PROTECTOR DOES NOT REDUCE RISK OF HIP FRACTURE FOR NURSING HOME RESIDENTS

>   IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS APPEAR EFFECTIVE IN HELPING TO PREVENT SUDDEN CARDIAC DEATH IN PATIENTS WITH CERTAIN HEART DISORDER

>   USE OF PULMONARY ARTERY CATHETER DECREASES SUBSTANTIALLY IN U.S.

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   IMPLANTABLE DEFIBRILLATORS EFFECTIVE IN PREVENTING SUDDEN DEATH AMONG HYPERTROPHIC CARDIOMYOPATHY PATIENTS

INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA Report video is on the effectiveness of implantable cardioverter-defibrillators in preventing sudden cardiac death in patients with a certain heart disorder. The report will be fed Tuesday, July 24, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 09, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, July 24, 2007
Media Advisory: To contact Douglas P. Kiel, M.D., M.P.H., call Jennifer Davis at 617-363-8384. To contact editorial co-author Pekka Kannus, M.D., Ph.D., email: pekka.kannus{at}uta.fi.

USE OF HIP PROTECTOR DOES NOT REDUCE RISK OF HIP FRACTURE FOR NURSING HOME RESIDENTS

CHICAGO—Use of an energy-absorbing hip protector did not provide a protective effect against hip fracture for nursing home residents, adding to increasing evidence that hip protectors, as currently designed, are not effective for preventing hip fractures, according to a study in the July 25 issue of JAMA.

"In the United States, nearly 340,000 hip fractures occur per year, more than 90 percent of which are associated with falls, and the number of hip fractures may double or triple by the middle of this century. The highest incidence rates of hip fractures have been reported in nursing home residents, where 50 percent of residents fall each year," the authors write. Hip protectors have been developed to reduce the impact of falls and risk of hip fractures. Previous studies regarding their effectiveness have had conflicting results.

Douglas P. Kiel, M.D., M.P.H., of Hebrew SeniorLife and Harvard Medical School, Boston, and colleagues conducted a randomized controlled trial from October 2002 to October 2004 to test the effectiveness of an energy-absorbing and energy-dispersing hip protector in reducing the incidence of hip fracture among nursing home residents. The trial included 37 nursing homes in which 1,042 residents (average age, 85 years; 79 percent women) wore a hip protector on 1 hip only so that each participant served as his or her own control. The average duration of participation for nursing home residents was 7.8 months. The hip protector consisted of an outer layer of polyethylene backed by a hard high-density polyethylene shield that was backed by ethylene vinyl acetate foam. Overall adherence of the participants was 73.8 percent.

After a 20-month follow-up, the study was terminated due to a lack of effectiveness. The researchers found that the incidence rate of hip fracture on protected hips (3.1 percent) did not differ from the incidence rate on unprotected hips (2.5 percent). Similarly, in analysis for the 334 residents with greater than 80 percent adherence, the incidence of hip fracture on protected hips (5.3 percent) did not differ from that on unprotected hips (3.5 percent).

"In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations. With the development of better pad materials and more thorough testing, future studies should examine new hip protectors using nonclustered randomized designs like ours to avoid many methodological biases," the authors write.
(JAMA. 2007;298(4):413-422. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

EDITORIAL: HIP PROTECTORS FOR PREVENTING HIP FRACTURE

In an accompanying editorial, Pekka Kannus, M.D., Ph.D., and Jari Parkkari, M.D., Ph.D., of the UKK Institute for Health Promotion Research, Tampere, Finland, comment on the findings of Kiel and colleagues.

"Although Kiel et al provide useful data from an important trial, these findings and those from past studies are not sufficient to make evidence-based recommendations for or against hip protectors among frail, nursing home residents. Given the wide variation in the biomechanical force attenuation capacity among various hip protector models and potential differences in adherence among users, the anti-fracture efficacy of each protector model should first be examined in vitro (as it was for the protectors used by Kiel et al) and then in actual falls, continuing with analyses of protector position at the time of fall impact, as well as user adherence. Additional randomized trials should be conducted in which the individual is randomized to hip protection or not, or the individual serves as his or her own control, as in the study by Kiel et al. ...The importance of this health problem-falls and hip fractures among older adults-should make the work a compelling ongoing priority for health research throughout the world."
(JAMA. 2007;298(4):454-455. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including author affiliations, financial disclosures, funding and support, etc.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, July 24, 2007
Media Advisory: To contact Barry J. Maron, M.D., call 612-810-4578. To contact editorial co-author Rick A. Nishimura, M.D., call Traci Klein at 507-284-5005.

IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS APPEAR EFFECTIVE IN HELPING TO PREVENT SUDDEN CARDIAC DEATH IN PATIENTS WITH CERTAIN HEART DISORDER

CHICAGO—High-risk patients with hypertrophic cardiomyopathy appear to have reduced risk of sudden cardiac death with an implantable cardioverter-defibrillator that terminates dangerous heart rhythm disorders, according to a study in the July 25 issue of JAMA.

Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden cardiac death in young people, including trained athletes. HCM is a genetic disease in which the heart muscle thickens abnormally, which can interfere with the heart's electrical system, increasing the risk for life-threatening abnormal heartbeats (arrhythmias). Only in the last few years has the implantable cardioverter-defibrillator (ICD) been systematically used as a potentially life-saving treatment in high-risk patients with HCM, according to background information in the article. An ICD is a device designed to quickly detect a life-threatening, abnormal heart rhythm, and attempt to convert the rhythm back to normal by delivering an electrical shock to the heart. The effectiveness and appropriate selection of HCM patients for this therapy is not certain.

Barry J. Maron, M.D., of the Minneapolis Heart Institute Foundation, Minneapolis, and colleagues examined the clinical risk profile and incidence and effectiveness of ICD intervention in patients with HCM. The researchers analyzed data from a multicenter registry of ICDs implanted between 1986 and 2003 in 506 patients with HCM, average age 42 years. Patients were judged to be at high risk for sudden death. Average follow-up was 3.7 years.

Risk factors analyzed included history of premature HCM-related sudden death in 1 or more first-degree or other relatives younger than 50 years; massive left ventricular hypertrophy (enlargement); a certain type of nonsustained ventricular tachycardia (abnormally rapid heart rhythm); and prior unexplained syncope (temporary loss of consciousness).

Of the 506 patients, 20 percent experienced 1 or more appropriate device interventions, in which the ICD terminated ventricular fibrillation (severely abnormal heart rhythm that results in cardiac arrest) or ventricular tachycardia. Intervention rates were 10.6 percent per year for secondary prevention after cardiac arrest (5-year cumulative probability, 39 percent), and 3.6 percent per year for primary prevention (5-year probability, 17 percent).

Time to first appropriate discharge was up to 10 years, with a 27 percent probability 5 years or more after implantation. For primary prevention, 35 percent of the patients with appropriate ICD interventions had undergone implantation for only a single risk factor; likelihood of appropriate discharge was similar in patients with 1, 2, or 3 or more risk markers.

"The results of this international, multicenter study show the effectiveness and reliability of the ICD in prevention of sudden cardiac death in high-risk patients with HCM," the authors write. "An important proportion of these device interventions occurred in patients who had undergone prophylactic ICD implantation for a single risk factor. Therefore, a single marker of high-risk status may justify consideration for a primary prevention defibrillator in selected patients with HCM."
(JAMA. 2007;298(4):405-412. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

EDITORIAL: HYPERTROPHIC CARDIOMYOPATHY, SUDDEN DEATH, AND IMPLANTABLE CARDIAC DEFIBRILLATORS — HOW LOW THE BAR?

In an accompanying editorial, Rick A. Nishimura, M.D., and Steve R. Ommen, M.D., of the Mayo Clinic College of Medicine, Rochester, Minn., comment on the findings of the study by Maron and colleagues.

"Patients who have experienced cardiac arrest or documented sustained ventricular tachycardia definitely should be considered for implantation of an ICD. Patients with 2 or more risk factors likely present a high enough risk to warrant implantation of an ICD. However, the decision to implant an ICD in any patient, especially one with a single risk factor, must include a thorough and earnest discussion of the accuracy of the current risk assessment tools, the risks and benefits of ICD therapy, and the individual patient's viewpoints on procedures, devices, and death. Such an approach will allow the patient-physician team to arrive at an individualized decision regarding ICD implantation."
(JAMA. 2007;298(4):452-454. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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Embargoed for Release: 3:00 p.m. CT, Tuesday, July 24, 2007
Media Advisory: To contact Renda Soylemez Wiener, M.D., call Peggy Willoughby at 802-296-5132. To contact editorial co-author Gordon D. Rubenfeld, M.D., M.Sc., call Karen Kelly at 416-978-5949.

USE OF PULMONARY ARTERY CATHETER DECREASES SUBSTANTIALLY IN U.S.

CHICAGO—Use of the pulmonary artery catheter decreased by 65 percent in the U.S. between 1993 and 2004, possibly due to growing evidence that this invasive procedure does not reduce the risk of death for hospitalized patients, according to a study in the July 25 issue of JAMA.

The pulmonary artery (PA) catheter (a thin, flexible tube that is inserted into a pulmonary artery) first became available as a practical diagnostic tool in 1970 and was rapidly embraced by critical care physicians, according to background information in the article. The PA catheter made measurements such as cardiac output and pressure within the small vessels in the lungs accessible to physicians at the bedside. "Many physicians assumed that these numbers could guide treatment and ultimately reduce mortality in critically ill patients. Within several years, PA catheterization was widely used throughout the United States. In the 1980s, 20 percent to 43 percent of seriously ill patients who were hospitalized were reported to undergo the procedure," the authors write.

In the mid and late 1980s, there were challenges to the benefits of this procedure. A turning point occurred in September 1996 when a multicenter observational study suggested an increased risk of death with PA catheterization, with an editorial calling for a moratorium on PA catheter use until a randomized controlled trial could be conducted. In the past 5 years multiple randomized trials and a meta-analysis have shown that this technology has no impact on the risk of death in diverse populations of critically ill patients. But it is not known how this information has changed the use of this procedure.

Renda Soylemez Wiener, M.D., and H. Gilbert Welch, M.D., M.P.H., of the Department of Veterans Affairs Medical Center, White River Junction, Vt., examined the trends in the utilization of PA catheterization from 1993-2004 using data from all U.S. states contributing to the Nationwide Inpatient Sample.

The researchers found that utilization of PA catheterization in the United States from 1993 to 2004 for all medical admissions decreased by 65 percent, from 5.66 to 1.99 per 1,000 medical admissions. Among patients who died during hospitalization, a group whose disease severity may be consistent across time, the relative decline was similar (67 percent). A significant change in trend occurred following the 1996 study that suggested an increased risk of death with PA catheterization. Among common diagnoses associated with PA catheterization, the decline was most prominent for heart attack, which decreased by 81 percent, and least prominent for septicemia (a disease caused by toxic microorganisms in the bloodstream), which decreased by 54 percent.

"We found that PA catheterization use in both medical and surgical admissions has declined substantially across the United States over the study period," the authors write. "...the national decrease in PA catheter utilization suggests that many physicians have responded appropriately to the evidence that PA catheterization does not reduce mortality."
(JAMA. 2007;298(4):423-429. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including author contributions and affiliations, financial disclosures, funding and support, etc.

EDITORIAL: THE PULMONARY ARTERY CATHETER, 1967-2007; REST IN PEACE?

In an accompanying editorial, Gordon D. Rubenfeld, M.D., M.Sc., of the University of Toronto, and colleagues write that hospitals should consider several options to address the increasingly rare procedure of PA catheterization.

"First, centers performing only a few PA catheterization procedures should consider not doing any. Because it is likely that centers that use PA catheters infrequently will derive even less benefit than the published studies that show no benefit, low-volume centers should carefully consider whether there is greater risk from performing only a few PA catheterizations than doing none. ...Second, if PA catheterization use is continued, the procedure should be limited to a small number of skilled clinicians. Specialized teams of clinicians devoted to specific tasks have demonstrated value in critical care."

"Third, consider alternate hemodynamic monitoring tools, but consider them skeptically until convincing outcome data are available. ...Fourth, continued use of PA catheterization demands intensive evaluation and education," the authors write. "In the waning years of PA catheterization when the risks of infrequent use may outweigh any unproven benefit, it is more important than ever to remain vigilant for common errors in PA catheter placement and data interpretation. Passive education may not be sufficient and hospitals that choose to continue to use PA catheters will need to invest in simulation experiences, hands-on training, and quality monitoring to maintain a vanishing skill."
(JAMA. 2007;298(4):458-461. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.

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JAMA REPORTS

VIDEO: Windows Media | Quicktime

IMPLANTABLE DEFIBRILLATORS EFFECTIVE IN PREVENTING SUDDEN DEATH AMONG HYPERTROPHIC CARDIOMYOPATHY PATIENTS

INTRO:
You may have heard about young, active people whose hearts suddenly stop beating while playing sports, for example. Many such cases involve a specific heart condition that puts young people at risk of sudden death. Now a new study says implantable defibrillators may save their lives. Mavis Prall explains in this week’s JAMA Report.

VIDEO:
B-ROLL
Wide of doctors looking at MRI images of heart
Close up of screen/image
Paul and Mary walking outside

AUDIO:
HYPERTROPHIC (hi-per-TRO-fic) CARDIOMYOPATHY (car-dee-oh-my-AH-path-ee) IS A GENETIC DISEASE CAUSING THICKENING OF THE HEART WALL. TWENTY-TWO YEAR OLD PAUL MCSWEENEY AND HIS MOM LEARNED HE HAD H-C-M WHEN HE WAS ELEVEN.

VIDEO:
SOT/FULL
@ :13
Super: Mary McSweeney
Paul’s mom
Runs :10

AUDIO:
"They said that he should limit his activity which is really tough for an 11-year old kid, and that he could live a normal life, but that there was a risk of sudden death."

VIDEO:
B-ROLL
Dr. Maron in exam room with Paul
Exterior Minneapolis Heart Foundation
Close up of hand holding defibrillator (no brand showing)
Paul reading a book

AUDIO:
IN HOPES OF REDUCING THAT RISK OF SUDDEN DEATH, PAUL’S DOCTOR, BARRY MARON (MARE-on) OF THE MINNEAPOLIS HEART INSTITUTE FOUNDATION, RECENTLY IMPLANTED A DEFIBRILLATOR IN PAUL’S CHEST, TO SEND ELECTRIC SHOCKS TO THE HEART IF IT STARTS BEATING IRREGULARLY. AND THAT’S JUST WHAT IT DID, WHEN PAUL TOOK A NAP AFTER STRESSFUL STUDYING FOR FINALS.

VIDEO:
SOT/FULL
@ :41
Super: Paul McSweeney
Has implantable defibrillator
Runs :11

AUDIO:
"I just abruptly woke up and I wasn’t really sure what had happened at that point in time, and I later went in for a medical check up and they confirmed the fact that I had been defibrillated."

VIDEO:
B-ROLL
Dr. Maron in exam room
GFX/JAMA COVER
Dr. Maron and Paul in exam room – Paul’s chest revealed

AUDIO:
DR. MARON WAS PART OF A STUDY PUBLISHED IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, WHICH SHOWS IMPLANTABLE DEFIBRILLATORS CAN OFFER HOPE FOR MANY H-C-M PATIENTS.

VIDEO:
SOT/FULL
@ 1:00
Super: Barry Maron, M.D.
Minneapolis Heart Institute Foundation
Runs :12

AUDIO:
"We have found that it is now possible to change the natural course of the disease for some patients by preventing sudden cardiac death."

VIDEO:
B-ROLL
Dr. Maron examining Paul, listening to his heart
Dr. Maron touching bulge in Paul’s bare chest where defibrillator is implanted

AUDIO:
DR. MARON SAYS THAT H-C-M PATIENTS MAY BENEFIT FROM AN IMPLANTABLE DEFIBRILLATOR EVEN IF THEY HAVE ONLY ONE RISK FACTOR, SUCH AS SUDDEN DEATH IN A CLOSE RELATIVE, FAINTING WHICH IS OTHERWISE UNEXPLAINED, OR MASSIVE THICKENING OF THE HEART WALL. PAUL IS CLEARLY AT RISK, SINCE THE DEFIBRILLATOR HAD TO SHOCK HIS HEART BACK TO NORMAL BEATING.

VIDEO:
SOT/FULL
Mary McSweeney
Paul’s mom
Runs :07

AUDIO:
"The timing was amazing. He got a defibrillator only months before he needed it and it saved his life."

VIDEO:
B-ROLL
Paul and Mary talking to Dr. Maron in hallway

AUDIO:
PAUL FEELS LUCKY AND GRATEFUL.

VIDEO:
SOT/FULL
Paul McSweeney
Has implantable defibrillator
Runs :07

AUDIO:
"I really do see this defibrillator and the medical team that installed it in me as really saving my life."

VIDEO:
B-ROLL
Paul and Mary walking outside

AUDIO:
HE HOPES THE DEFIBRILLATOR WILL CONTINUE TO PROTECT HIM, AND THAT DEFIBRILLATORS CAN HELP OTHER H-C-M PATIENTS AS WELL. THIS IS MAVIS PRALL WITH THE JAMA REPORT.

TAG:
Dr. Maron and his colleagues studied data from about five hundred H-C-M patients from around the U.S. and abroad, who had implantable defibrillators. Over about three years, the defibrillators sent electric shocks to the one-hundred-and-three patients who had irregular heartbeats during the study. About twenty percent of participants experienced defibrillator complications and one patient died as a result of a defibrillator malfunction. For more information, visit www.jama.com.

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